Our team will bring their expertise and specialized skill sets to your project. We offer a full range of services across a variety of therapeutic areas and guarantee responsiveness and open communication throughout every step!
The TCTM team takes ownership of their projects and serve as a single point of contact and liaison between the sponsor, sites and vendors. The depth and responsiveness of our project management team is a core strength of the team. All project managers have at least 10 years of clinical research experience. This experience is a key component to TCTM having completed all target enrollment goals either early or on time.
The depth and responsiveness of our project management team is a core strength of the TCTM team.
We identify the best sites through in-depth research and feasibility to determine the best fit for your project. Our site database includes metrics on performance, accountability, responsiveness and diversity assessment scores.
Start-up is a critical period of the site/CRO engagement. The tone is set at this time and a positive approach out of the gate is the key to successful outcomes.
Whether the emphasis is on rare disease, diverse inclusion, difficult to recruit populations or less complex populations, planning is essential. As seasoned recruitment and retention experts, there is never a program that leaves enrollment to chance.
The remote and on-site monitoring team provided by TCTM are experienced and receive extensive customer relationship training. Monitoring services include comprehensive risk-based monitoring plans customized to meet your clinical trial design, support for 100% source document verification or risk-based monitoring strategies, immediate attention and resolution to issues of protocol noncompliance, remote monitoring, centralized monitoring, site initiation, interim and close-out visits along with on-going formal training programs.
The ultimate goal of any clinical trial is clean and quality data leading to on time database lock. An audit ready approach is always top of mind providing datasets under effective data governance, which will be locked on or before the agreed upon data. We employ a philosophy of total quality management to increase our productivity and decrease our error rates on each and every project as we strive to continually increase value to our clients.
The medical writing team employed are sought after experts and hold extensive experience in protocol development, informed consent, PK/PD report, clinical study report, abstracts, IRB approved patient facing materials, posters, regulatory submissions, and investigator brochure development.
A creative approach to patient recruitment has led us to consistently meet or exceed enrollment timelines on every project. Our expertise in recruitment planning is second to none. We work closely with the sites to determine the best recruitment plan for their location, as well as create custom nationwide study campaigns.
TCTM will tailor recruitment planning specifically for your study and guarantee cost-effective, measurable results.
Learn more about our enrollment success.
TCTM has a multifaceted approach to patient recruitment and retention along with a proven track record of success. We maintain a retention rate of 93% for all completed studies.
Our project team implements a customized retention plan at the start of each study, with a heavy emphasis on addressing the needs of each site. Throughout the study, we consistently monitor and track enrollment results, allowing us to identify any potential retention issues early on continually through the life of the study.
The quality management team will ensure your study withstands regulatory scrutiny and adheres to FDA Good Clinical Practice compliance guidelines from study inception to database lock. Our team operates with a sense of urgency to proactively identify early quality events and provide a prompt resolution, resulting in the sustained momentum of your study to meet targeted deadlines.
The services we provide include: trial specific audits, root cause analysis, corrective and preventive action plans, development of risk management and quality improvement plans, quality documentation reports, serious adverse event coordination, validation of quality process, central study TMF audits and determining system requirements for your study.